Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal

This study has been completed.

Sponsor:

Collaborators:

Scentryphar Clinical Research

Cori Analyticals

Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C

LabClin Laboratório Clínico

Laboratório de Patologia Clínica Dr. Franceschi Ltda.

Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00905333

First received: May 19, 2009

Last updated: December 6, 2010

Last verified: December 2010

History of Changes

Purpose

The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®

Condition	Intervention	Phase
Healthy	Drug: Candesartan (test) Drug: Felodipine (test) Drug: Candesartan Cilexetil Drug: Felodipine	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Felodipine Candesartan Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. [ Time Frame: 76 blood samples per subject ]


Enrollment:	36
Study Start Date:	October 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single-arm 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)	Drug: Candesartan (test) 16 mg oral tablet, single dose Drug: Felodipine (test) 5 mg oral extended release tablet, single dose Drug: Candesartan Cilexetil 16 mg oral tablet, single dose Other Name: Atacand® Drug: Felodipine 5 mg oral extended release tablet, single dose Other Name: Splendil®

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers
BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)

Exclusion Criteria:

Not healthy
Chronic drug intake

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905333

Locations


Brazil
Research Site
Itatiba, SP, Brazil
Research Site
Americana, Brazil

Sponsors and Collaborators

AstraZeneca

Scentryphar Clinical Research

Cori Analyticals

Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C

LabClin Laboratório Clínico

Laboratório de Patologia Clínica Dr. Franceschi Ltda.

Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência

Investigators


Principal Investigator:	Eduardo Abib Junior, MD	Scentryphar Clinical Research
Study Chair:	Moises L. P Vanuncci, MD	Scentryphar Clinical Research

More Information


Responsible Party:	MC MD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00905333 History of Changes
Other Study ID Numbers:	D2452L00021 IMPACT 15381
Study First Received:	May 19, 2009
Last Updated:	December 6, 2010

Keywords provided by AstraZeneca:


pharmacokinetics candesartan felodipine test formulations Atacand®	Splendil® healthy volunteers blood samples after meal intake interaction Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.

Additional relevant MeSH terms:


Candesartan cilexetil Candesartan Felodipine Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists	Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents

ClinicalTrials.gov processed this record on June 22, 2017

To Top